The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers

Not Applicable

Withdrawn

• Conditions: Tobacco Use
• Interventions: Behavioral: E-liquid sampling and preference assessment

• Registration Number: NCT03186911
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Status Verified: 2018-10
• Study Start: 2019-07
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• At least 18 years old
• Daily cigarette smoking
• Have tried vaping devices on a minimum of one lifetime occasion

Exclusion Criteria

• Unwilling to use a vaping device during the session
• Break alcohol level > 0.01 (g/dL)
• Pregnant, trying to become pregnant, or breastfeeding
• Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
• Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
• Heart rate greater than or equal to 105 bpm or lower than 45 bpm
• A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-liquid Group	E-liquid sampling and preference assessment	Participants will sample two different e-liquids.

Primary Outcome Measures

Name	Time	Method
Product Evaluation Questionnaire	One Day	Ratings of the two e-liquids on a self-report questionnaire

Secondary Outcome Measures

Name	Time	Method
Preference Assessment	One Day	Choices of each of the two e-liquids on a preference assessment
Vaping Purchase Task	One Day	Hypothetical estimates of consumption of each of the e-liquids across a variety of prices
Perceived Health Risk Questionnaire	One Day	Personal Health Risk Ratings about each of the two e-liquids